Device product
Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.
Z-1103-2021
Product summary
- Event
- Event 87189
- Status
- Terminated
- Classification
- Class II
- Quantity
- 60 sleeves
- Official record key
device-enforcement:Z-1103-2021
Official wording
Reason: The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots.
Code information: Product No.: 129453216, 129453226, 129453236,129453246 Lot No.: J85Y90, J86T23, J86T20, J8790J, J85Y92
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of AK, CA, FL, IN, MI, MN, MS, NC, NY, OH, PA, TX, VA and the countries of Canada, China, Germany, Puerto Rico, Switzerland.
Derived failure modes
-
Potency or specification failure
out of specification